(86 days)
The Medical Diode Laser Hair Removal System is used for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types ( Fitzpatrick I-VI), including tanned skin.
Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through an LCD touch-screen. In the handpiece of the machine, the light emitted by each discharge at 808nm.
This appears to be a 510(k) summary for a Medical Diode Laser Hair Removal System. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not available in this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
This document does not present a formal table of "acceptance criteria" for clinical performance. Instead, it demonstrates "substantial equivalence" to predicate devices, meaning it aligns well with the performance and safety profiles of already cleared devices.
The "performance" discussed is primarily technical compliance with electrical, EMC, and laser safety standards, and matching the intended use of predicate devices.
| Acceptance Criteria Category | Reported Device Performance (from the document) |
|---|---|
| Intended Use | The Medical Diode Laser Hair Removal System is used for permanent reduction in hair regrowth defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin. |
| (This is shared with predicate devices, indicating consistency in intended outcome). | |
| Product Code | GEX (Same as predicate devices) |
| Regulation No. | 21 CFR 878.4810 (Same as predicate devices) |
| Class | II (Same as predicate devices) |
| Wavelength | 808 nm (Same as one predicate, similar to another's 810nm) |
| Light/Laser source | Diode (Same as predicate devices) |
| How supplied | Non-sterile, cleanable (Same as predicate devices) |
| Fluence (Energy Density) | 48 J/cm² (Similar to predicate devices: 40 J/cm² and 6-90 J/cm²) |
| Rep Rate [Hz] | 1-10 Hz (Similar to predicate devices: 1-5 Hz and ≤ 10 Hz) |
| Pulse Duration [ms] | 1-300 ms (Similar to predicate devices: 30-200 ms and Up to 310 ms) |
| Spot Size | 1.44 cm² (1.2 x 1.2 cm) (Similar to predicate devices: 1.20 cm² and 1.92 cm²) |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 (Same as predicate devices) |
| EMC | Comply with IEC 60601-1-2 (Same as predicate devices) |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 (Same as predicate devices) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical study is included in this submission." Therefore, there is no test set, sample size, or data provenance from a clinical study to report. The evaluation is based on non-clinical (bench) testing and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a laser hair removal system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a laser hair removal system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study was conducted to establish performance against a clinical ground truth. The "ground truth" equivalent for this submission is regulatory compliance with standards and equivalence to predicate devices.
8. The sample size for the training set
Not applicable, as no clinical study was conducted.
9. How the ground truth for the training set was established
Not applicable, as no clinical study was conducted.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.